Fresh Recalls

ICU Medical recalls

16 recent recalls on record for ICU Medical in connected official government data as of October 22, 2026 at 6:00 PM UTC.

Models with recalls

CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes (1)Hotline Fluid Warming Set (1)IV Non-Dedicated Gravity Administration Sets with drip chambers (1)IV Sets with drip chambers (4)Oncology Kit w/60" (152 cm) Appx 2 (1)Oncology sets with drip chambers (2)Plum Duo Infusion Pump (2)Plum Duo Precision IV Pump (1)Plum Solo Precision IV Pump (2)Plum administration sets (1)

All ICU Medical recalls

FDA Class II · Medical device · September 23, 2026

CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes recall — ICU Medical, Inc.

Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, expo…

Official ID Z-3212-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

IV Sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Official ID Z-3163-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

IV Sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Official ID Z-3162-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

IV Sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Official ID Z-3161-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

IV Sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Official ID Z-3160-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Oncology sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Official ID Z-3159-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Oncology sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Official ID Z-3158-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

IV Non-Dedicated Gravity Administration Sets with drip chambers recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Official ID Z-3157-2026 · Official record ↗

FDA Class II · Medical device · September 23, 2026

Plum administration sets recall — ICU Medical, Inc.

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…

Official ID Z-3156-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

Hotline Fluid Warming Set recall — ICU Medical Inc.

ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing t…

Official ID Z-2759-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

ICU Medical Plum Solo Precision IV Pump recall — ICU Medical, Inc.

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

Official ID Z-2724-2026 · Official record ↗

FDA Class II · Medical device · July 22, 2026

ICU Medical Plum Duo Infusion Pump recall — ICU Medical, Inc.

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

Official ID Z-2723-2026 · Official record ↗

FDA Class II · Medical device · June 17, 2026

Plum Duo Precision IV Pump recall — ICU Medical, Inc.

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may…

Official ID Z-2313-2026 · Official record ↗

FDA Class II · Medical device · June 17, 2026

Plum Duo Infusion Pump recall — ICU Medical, Inc.

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may…

Official ID Z-2312-2026 · Official record ↗

FDA Class II · Medical device · June 17, 2026

Plum Solo Precision IV Pump recall — ICU Medical, Inc.

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may…

Official ID Z-2311-2026 · Official record ↗

FDA Class II · Medical device · May 27, 2026

Oncology Kit w/60" (152 cm) Appx 2 recall — ICU Medical, Inc.

Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy …

Official ID Z-2210-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.